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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37602
Event Type  Injury  
Event Description

It was reported that the patient had started going downhill in (b)(6) 2014. The patient had started falling a lot in (b)(6) 2014 which was why the patient had to be put into a nursing home on (b)(6) 2015. It was noted that after one of the patient¿s falls onto the floor the patient was placed in a hospital but it was unknown when the patient was admitted or when the fall was. The patient was released from the hospital on (b)(6) 2015 and was then admitted to the nursing care facility. The patient had fallen through the shower door, by the shower and a couple of times by the bed. The healthcare professional had done x-rays and everything was fine. The patient had very low blood pressure and took medication to bring the blood pressure up. It was noted that there were also times where he got up right away and he should not be doing that. The patient was in a wheelchair and does not walk with his walker. Starting in (b)(6) 2014 the patient had also been having trouble swallowing anything. The patient coughed a lot when he ate and even when he drank water. One day the patient had coughed really badly for a quite a while. The patient¿s wife pureed the food for patient and added thickening for liquids. On (b)(6) 2015 they had done a swallowing/aspiration test and it was pretty bad. The patient might get a g-tube for feeding purposes. The patient¿s last battery had lasted from 2005 to 2011 and they thought this battery would last for 5 years. The patient¿s family thought the battery was getting low because the patient was having neurological and swallowing issues which were symptoms that the patient usually had when their battery was getting low. The family wanted the implantable neurostimulator (ins) checked before placing the g-tube. The healthcare professional was unsure if the patient was getting benefit from the deep brain stimulator. No intervention or outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted. Reference manufacturer¿s report number: 3004209178-2015-07114.

 
Manufacturer Narrative

Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator. Product id: 3389s-40, lot# v010293, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 748295, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. (b)(4).

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263987
MDR Report Key4684090
Report Number3004209178-2015-07116
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/28/2012
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Date Manufacturer Received03/23/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/13/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/13/2015 Patient Sequence Number: 1
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